Senior Project Lead Statistician - Vaccine

Job title: Senior Project Lead Statistician - Vaccine

• Location: Waltham, MA or Swiftwater, PA (must have ability to work onsite 2-3 days per week per Hybrid working policy)

About the Job

As the Senior Project Lead Statistician, you will ask as a biostatistics expert at vaccine project level. You will develop with other clinical/medical and global project team members the end-to-end clinical development plan for the vaccine.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities

• Contribute with clinical and project team members to the internal approval of the plan by governing bodies at platform and cross platforms level

• Propose alternative trials design options, bringing innovative approaches where it adds value with the support of the Statistical Innovation team.

• Contribute with project team members (i.e. clinical, pharmacovigilance, regulatory) to gain Health Authorities acceptance of the plans, accountable from a statistical standpoint. Seek support from the Biostats Franchise Lead as needed.

• Oversee for his/her project the execution of the respective clinical trials: Data capture, Randomization, Statistical Analysis Plan, Analyses deliveries for primary and secondary objectives. May be in charge of the most complex/priority study in the project.

• Communicate internally the trials results (Key Results Memo) work cross-functionally to the scientific interpretation of the results and evaluation of strategic impact on the plan.

• Contribute to the external communication of the study results to Health Authorities

• Accountable for the statistical aspects of the submission for marketing authorization or label improvement

• Act as Statistics representative in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards

• Sanofi Vaccines representative in cross-company activities such as consortiums or professional associations

About You

• Ph.D. or MS in Biostatistics, Mathematics or related discipline is required

• Minimum 6+ years biostatistics experience in pharmaceutical industry

• Proven experience in clinical development or post-marketing activities

• Demonstrated strong project management & interpersonal skills. Strong team player.

• Broad knowledge and good understanding of advanced statistical concepts and techniques

• Strong skills with SAS, R

• Effective English oral and written communication skills

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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